Extracorporeal circulation simulation system

Abstract

An extracorporeal circulation simulation system comprises a ventricle simulation device, an arterial valve clamping device, a catheter pump and a simulation pipeline. The ventricle simulation device is provided with a fluid outlet and a fluid inlet, the arterial valve clamping device comprises an inlet flange, an outlet flange and a simulation arterial valve, the inlet flange is communicated with the fluid outlet, the outlet flange is communicated with the fluid inlet, a catheter pump can extend into the arterial valve clamping device, and the simulation pipeline is communicated with the ventricle simulation device and the arterial valve clamping device. And the simulation pipeline is provided with a first valve and a second valve at the two ends of the arterial valve clamping device respectively. According to the extracorporeal circulation simulation system, the first valve and the second valve are arranged, circulation of fluid of the simulation pipeline at the catheter pump can be cut off, it is not needed to wait for emptying of fluid in the whole extracorporeal circulation simulation system, and a user can directly detach the arterial valve clamping device and replace the arterial valve clamping device with a new catheter pump. And after replacement is completed, the first valve and the second valve are opened to enable the extracorporeal circulation simulation system to recover operation, and the operation is simple and convenient.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to an extracorporeal circulation simulation system. Background Art

[0002] Heart failure is a serious cardiovascular disease, and its incidence is increasing with the aging population. Besides end-stage heart failure, heart failure can also occur as a complication or acute symptom. For example, patients with high-risk coronary artery disease who require percutaneous coronary intervention (PCI) often experience acute heart failure. Symptoms such as myocardial ischemia or arrhythmias may occur during treatment, posing a risk of hemodynamic compromise. Therefore, cardiac assist is required to maintain left ventricular function during treatment. Cardiogenic shock is an extreme manifestation of heart failure. Severe heart failure can cause acute peripheral circulatory failure. This sudden onset of illness urgently requires a rapid assist device to restore ventricular function and potentially save lives. Unlike traditional left ventricular assist devices (LVADs), which have long lifespans and low replacement rates, invasive ventricular assist devices (PVADs) offer a shorter treatment time, are convenient and efficient to implant, and are minimally invasive. They also reduce the complexity and time required by physicians during PCI procedures, significantly lowering the surgical risk for heart failure patients. Therefore, interventional treatment for heart failure has been hailed as the next wave in cardiovascular intervention.

[0003] Interventional catheter pumps are Class III medical devices, and their performance requirements are high in actual clinical applications. They must not only demonstrate excellent hemodynamic properties but also good stability when assisting with heart failure. Therefore, prior to formal clinical trials, it is necessary to utilize an in vitro simulation system to truly reflect the complex physiological states of heart failure patients and to explore the hemodynamic properties and operational stability of catheter pumps in complex clinical scenarios. Performance testing and research on different catheter pumps typically requires draining the entire in vitro simulation system before replacement. This is time-consuming and cumbersome, and can easily lead to fluid leakage within the simulation system, resulting in unnecessary waste.

[0004] Therefore, how to improve the technical defects in the existing technology and develop an in vitro simulation system that can quickly disassemble and assemble a catheter pump has always been an urgent problem to be solved by ordinary technicians in this field. Utility Model Content

[0005] The purpose of this application is to provide an extracorporeal circulation simulation system that can achieve rapid disassembly and assembly of the catheter pump, simplify the operating steps, reduce fluid leakage that may occur during the replacement process, and avoid unnecessary waste.

[0006] The technical solutions provided in this application are as follows:

[0007] An extracorporeal circulation simulation system, comprising:

[0008] a ventricular simulation device having a fluid outlet and a fluid inlet;

[0009] An arterial valve clamping device comprising an inlet flange, an outlet flange, and a simulated arterial valve sandwiched between the inlet flange and the outlet flange, wherein the inlet flange is connected to the fluid outlet, the outlet flange is connected to the fluid inlet, and the outlet flange is suitable for allowing a catheter pump to extend into the interior of the arterial valve clamping device and partially pass through the simulated arterial valve;

[0010] The simulation pipeline is connected with the ventricle simulation device and the aortic valve clamping device, and the simulation pipeline is provided with a first valve and a second valve at both ends of the aortic valve clamping device.

[0011] In some embodiments, the outlet flange is provided with a bypass tube, one end of which is located inside the aortic valve clamping device, and the other end passes through the side wall of the outlet flange and extends to the outside of the outlet flange, and the catheter pump extends into the interior of the aortic valve clamping device through the bypass tube.

[0012] In some embodiments, the aortic valve clamping device further includes a blocking member adapted to block an end of the bypass tube located outside the outlet flange.

[0013] In some embodiments, the extracorporeal circulation simulation system further comprises:

[0014] The simulation branch connects the bypass pipe and the simulation pipeline.

[0015] In some embodiments, the extracorporeal circulation simulation system further comprises:

[0016] The first flow meter is installed on the simulation branch and is used to detect the flow on the simulation branch.

[0017] In some embodiments, the extracorporeal circulation simulation system further comprises:

[0018] a first pressure sensor and a second pressure sensor;

[0019] The first pressure sensor is provided in the simulation pipeline and is located on a side of the inlet flange away from the outlet flange. The second pressure sensor is provided in the simulation pipeline and is located on a side of the outlet flange away from the inlet flange.

[0020] In some embodiments, the first valve is located on a side of the inlet flange away from the outlet flange, the second valve is located on a side of the outlet flange away from the inlet flange, and one end of the simulation branch connected to the simulation pipeline is located between the second valve and the second pressure sensor.

[0021] In some embodiments, the second valve is located on a side of the second pressure sensor close to the aortic valve clamping device.

[0022] In some embodiments, the ventricular simulation device includes a first simulation chamber, a second simulation chamber located within the first simulation chamber, and a mounting frame for fixing the first simulation chamber and the second simulation chamber;

[0023] The first simulation chamber and the second simulation chamber are isolated from each other, and a first medium cavity is formed between the first simulation chamber and the second simulation chamber. The first simulation chamber has a medium flow port connected to the first medium cavity. The second simulation chamber has a second medium cavity formed therein, and the second medium cavity is connected to the fluid outlet and the fluid inlet.

[0024] The medium in the first medium cavity is suitable for applying pressure to the second simulation chamber, and the medium flow port is configured to allow the medium to flow so as to change the medium content in the first medium cavity and cause the second simulation chamber to expand or contract.

[0025] In some embodiments, the extracorporeal circulation simulation system further comprises:

[0026] An air pump and a controller for controlling the operation of the air pump, wherein the air pump is connected to the medium flow port through an air pipe to fill or suck the medium into the first medium cavity.

[0027] The technical effects of this application are:

[0028] 1. In the present application, by providing a first valve and a second valve at both ends of the arterial valve clamping device, the user can cut off the fluid flow at the catheter pump by closing the first valve and the second valve, thereby disassembling the arterial valve clamping device and replacing the catheter pump, eliminating the step of emptying the fluid in the simulated pipeline, making the operation simpler and less time-consuming. In addition, during the process of replacing the catheter pump, since the first valve and the second valve cut off the fluid flow, the fluid in the simulated pipeline is less likely to leak to the outside and cause waste. After the catheter pump is replaced, reopening the first valve and the second valve can quickly restore the fluid circulation in the extracorporeal circulation simulation system. The operation is convenient, which is beneficial for users to conduct a large number of performance tests on different catheter pumps.

[0029] 2. In this application, the outlet flange of the aortic valve clamping device is also equipped with a bypass tube for the catheter pump to pass through. This bypass tube not only allows users to independently measure the pumping flow rate of the catheter pump and study its pumping performance, but also facilitates replacement of the catheter pump. For example, the user can control the catheter pump to evacuate from the bypass tube, allowing the catheter pump to be removed without disassembling the aortic valve clamping device. The bypass tube is also equipped with a sealing member at one end outside the outlet flange, which reduces fluid leakage and waste during operation of the catheter pump, while also improving the accuracy of the user's measurement of the catheter pump's pumping flow rate.

[0030] 3. In this application, the second valve is located on the side of the second pressure sensor near the aortic valve clamping device, and the end of the analog branch connecting to the analog pipeline is located between the second valve and the second pressure sensor. By placing the second pressure sensor after the convergence of the analog branch and the analog pipeline, this application facilitates the user to obtain arterial pressure and evaluate the actual performance of the catheter pump. Placing the second valve before the convergence can cut off the main circulation circuit (excluding the circulation circuit pumped by the catheter pump), making it easier to replace the catheter pump and providing a more reasonable and practical structural arrangement.

[0031] 4. In this application, the ventricular simulation device includes a first simulation chamber and a second simulation chamber. The first simulation chamber is arranged outside the second simulation chamber. By changing the medium pressure between the first simulation chamber and the second simulation chamber (in the first medium chamber), the state of the second simulation chamber can be changed. For example, when the medium pressure increases, the second simulation chamber contracts, and when the medium pressure decreases, the second simulation chamber relaxes. In this way, the contraction and relaxation of the left ventricle (or right ventricle) can be accurately simulated, thereby driving the circulation of the medium in the second simulation chamber, creating a pulsating environment that simulates the physical state of a heart failure patient, and facilitating the testing and research of the hemodynamic characteristics and operational stability of the catheter pump in complex clinical scenarios. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] The present application is further described in detail below with reference to the accompanying drawings and specific embodiments:

[0033] Figure 1 This is a schematic structural diagram of an extracorporeal circulation simulation system provided in one embodiment of the present application;

[0034] Figure 2 This is a cross-sectional view of the aortic valve clamping device provided in one embodiment of the present application when no catheter pump is installed;

[0035] Figure 3 This is a cross-sectional view of an aortic valve clamping device provided in one embodiment of the present application when a catheter pump is inserted therethrough;

[0036] Figure 4This is a perspective view of the three-dimensional structure of a ventricular simulation device provided in one embodiment of the present application.

[0037] Description of Figure Numbers:

[0038] 100, ventricular simulation device; 110, first simulation chamber; 120, second simulation chamber; 121, second medium chamber; 130, first medium chamber; 140, medium flow port; 150, mounting frame; 160, fluid outlet; 170, fluid inlet;

[0039] 200, aortic valve clamping device; 210, inlet flange; 220, outlet flange; 221, bypass tube; 222, blocking member; 230, simulated aortic valve; 240, first sealing gasket; 250, pressing member; 260, second sealing gasket;

[0040] 301. Air pump control unit; 302. Trachea; 303. Flow regulating valve; 304. Atrioventricular valve simulation device; 305. Simulation pipeline; 306. Catheter pump; 3061. Fluid inflow window; 3062. Fluid outflow window; 307. First pressure sensor; 308. Second pressure sensor; 309. Damping valve; 310. Compliance chamber; 311. Venous cavity; 312. Left atrium simulation device; 313. Second flowmeter; 314. Simulation branch; 315. First valve; 316. Second valve. DETAILED DESCRIPTION

[0041] In the following description, specific details such as specific system structures and technologies are provided for illustration rather than limitation to facilitate a thorough understanding of the embodiments of the present application. However, it should be clear to those skilled in the art that the present application may be implemented in other embodiments without these specific details. In other cases, detailed descriptions of well-known systems, devices, circuits, and methods are omitted to avoid obstructing the description of the present application with unnecessary details.

[0042] In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the specific implementation methods of the present application will be described below with reference to the accompanying drawings. Obviously, the drawings described below are only some embodiments of the present application. For those skilled in the art, other drawings and other implementation methods can be obtained based on these drawings without inventive work.

[0043] To simplify the drawings, only the parts relevant to the utility model are schematically shown in each figure; they do not represent the actual structure of the product. Furthermore, to simplify the drawings and facilitate understanding, in some figures, only one of the components with the same structure or function is schematically depicted or labeled. In this document, "one" not only means "only one" but also "more than one."

[0044] It should be further understood that the term "and / or" used in this specification and the appended claims refers to and includes any and all possible combinations of one or more of the associated listed items.

[0045] It should be noted that, unless otherwise specified or limited, the terms "mounted," "connected," and "connected" should be understood broadly. For example, they can refer to fixed, detachable, or integral connections; mechanical or electrical connections; direct or indirect connections through an intermediary; and internal communication between two components. Those skilled in the art will understand the specific meanings of these terms in this application based on the specific circumstances.

[0046] In the embodiments shown in the accompanying drawings, directional indications (such as up, down, left, right, front, and back) are used to explain the structure and movement of various components of the present application, not absolute but relative. These descriptions are applicable when these components are in the positions shown in the accompanying drawings. If the descriptions of the positions of these components are changed, these directional indications will also change accordingly.

[0047] In addition, in the description of the present application, the terms "first", "second", etc. are only used to distinguish the description and cannot be understood as indicating or implying relative importance.

[0048] As an invasive ventricular assist device, a catheter pump, once implanted, works with the heart of a heart failure patient to maintain normal blood circulation. This assistance requires not only excellent hemodynamic properties but also good stability. Therefore, prior to formal clinical trials, it is necessary to utilize an in vitro simulation system to realistically reflect the complex physiological states of heart failure patients and to explore the hemodynamic properties and operational stability of the catheter pump in complex clinical scenarios.

[0049] During the in vitro simulation process, catheter pumps may need to be replaced or disassembled. For example, when users conduct multi-scenario or single-scenario performance tests on different catheter pumps, the catheter pumps in the in vitro simulation system need to be replaced. However, when replacing catheter pumps in current in vitro simulation circulatory systems at home and abroad and on the market, the fluid in the entire in vitro simulation system must be drained before the catheter pump can be replaced. This is time-consuming and cumbersome, and can easily lead to fluid leakage within the in vitro simulation system, resulting in unnecessary waste.

[0050] In response to the above problems, the present application proposes an extracorporeal circulation simulation system that can achieve rapid replacement of the catheter pump, reduce fluid leakage that may occur during the replacement process, and avoid unnecessary waste.

[0051] For example, see Figures 1 to 3 An extracorporeal circulation simulation system includes a ventricular simulation device 100, an aortic valve clamping device 200, and a simulation pipeline 305. The ventricular simulation device 100 is used to simulate the human ventricle and has a fluid outlet 160 and a fluid inlet 170. The aortic valve clamping device 200 includes an inlet flange 210, an outlet flange 220, and a simulated aortic valve 230 sandwiched between the inlet flange 210 and the outlet flange 220. The simulated aortic valve 230 is used to simulate the human aortic valve and can achieve unidirectional flow of fluid in the extracorporeal circulation simulation system. In contrast, the simulated conduit 305 is used to simulate an artery, simulating the shape and elasticity of a human arterial conduit. The inlet flange 210 connects to the fluid outlet 160 via the simulated conduit 305, while the outlet flange 220 connects to the fluid inlet 170 via the simulated conduit 305. This allows for a complete circulation loop to be formed between the ventricular simulator 100 and the simulated aortic valve 230. Because the ventricular simulator 100 can simulate the pulsating function of the human heart, and the simulated aortic valve 230 enables unidirectional fluid flow, the ventricular simulator 100 can drive the circulation of the medium within this circulation loop, thereby creating a pulsating environment that simulates the physical state of a heart failure patient. At this point, the catheter pump 306 can extend from one side of the outlet flange 220 into the interior of the aortic valve clamping device 200 and partially penetrate the simulated aortic valve 230, allowing users to test and study the hemodynamic characteristics and operational stability of the catheter pump 306 in complex clinical scenarios.

[0052] In this embodiment, the simulated tubing 305 is further provided with a first valve 315 and a second valve 316 at both ends of the aortic valve clamping device 200. The first valve 315 and the second valve 316 are preferably ball valves. By closing the first valve 315 and the second valve 316, the user can cut off the fluid flow in the circulation circuit at the catheter pump 306, thereby disassembling the aortic valve clamping device 200 and replacing the catheter pump 306. This eliminates the need to empty the fluid in the simulated tubing 305, making the operation simpler and less time-consuming. Furthermore, during the replacement of the catheter pump 306, since the first valve 315 and the second valve 316 cut off the fluid flow, the fluid in the simulated tubing 305 is less likely to leak out and cause waste. After the catheter pump 306 is replaced, reopening the first valve 315 and the second valve 316 quickly restores the fluid circulation in the circulation circuit. This convenient operation facilitates the user to conduct extensive performance testing of different catheter pumps 306, thereby collecting performance data for the catheter pumps 306 and laying a foundation for product development.

[0053] In the actual test process, see Figure 3 The fluid inflow window 3061 on the catheter pump 306 should be located on the side of the simulated arterial valve 230 facing the inlet flange 210 to simulate the catheter pump 306 pumping blood across the valve.

[0054] Preferably, see Figures 1 to 3 The outlet flange 220 is provided with a bypass tube 221. One end of the bypass tube 221 is located inside the aortic valve clamping device 200, and the other end extends through the sidewall of the outlet flange 220 and out of the outlet flange 220. The distal end of the catheter pump 306 (the end away from the operator) can be extended into the aortic valve clamping device 200 through the bypass tube 221 until the fluid inlet window 3061 of the catheter pump 306 is located on the side of the simulated aortic valve 230 facing the inlet flange 210. At this point, the fluid outlet window 3062 of the catheter pump 306 is located exactly within the bypass tube 221, allowing the fluid pumped by the catheter pump 306 to flow completely into the bypass tube 221 after flowing out of the fluid outlet window 3062.

[0055] In this embodiment, the bypass pipe 221 is provided to isolate the fluid pumped by the catheter pump 306, so that the pumping performance of the catheter pump 306 is more concretely displayed, which is conducive to the user's accurate evaluation of the pumping performance of the catheter pump 306 and improves the accuracy of the flow estimation of the catheter pump 306 in clinical practice.

[0056] In addition, to facilitate the user to further study and analyze the performance of the catheter pump 306, the bypass pipe 221 should be connected to the simulation pipeline 305 to obtain the total fluid flow, so that the user can better analyze the flow pumped by the catheter pump 306 when working in different pulsating environments.

[0057] Specifically, see Figure 1 The extracorporeal circulation simulation system further includes a simulation branch 314, which is used to connect the bypass pipe 221 and the simulation pipeline 305, and the simulation branch 314 is preferably connected to the bypass pipe 221 near one end located outside the outlet flange 220.

[0058] In this embodiment, by positioning the simulated branch 314 near the end of the bypass tube 221 located outside the outlet flange 220, the fluid pumped by the catheter pump 306 can be completely channeled into the simulated tube 305 via the simulated branch 314, thereby improving the accuracy with which the user can obtain the total fluid flow rate. Furthermore, the simulated branch 314 does not occupy the space at the end of the bypass tube 221 located outside the outlet flange 220, allowing the catheter pump 306 to enter and exit the aortic valve clamping device 200 directly through the end of the bypass tube 221 located outside the outlet flange 220. This allows the user to control the catheter pump 306 to enter or exit the aortic valve clamping device 200 through the bypass tube 221 without disassembling the aortic valve clamping device 200, thereby enabling the catheter pump 306 to be replaced more conveniently and quickly.

[0059] Among them, the aortic valve clamping device 200 also includes a sealing member 222, which is used to seal the end of the bypass tube 221 located outside the outlet flange 220 after the catheter pump 306 is replaced, thereby avoiding leakage of fluid from the bypass tube 221 during the operation of the catheter pump 306, reducing waste, and improving the accuracy of users' measurement of the pumping flow rate and total fluid flow rate of the catheter pump 306.

[0060] Further, see Figure 2 and Figure 3 A first sealing gasket 240 should also be provided at the joint between the inlet flange 210 and the outlet flange 220 to reduce fluid leakage that may occur at the joint after the inlet flange 210 and the outlet flange 220 are mated with each other, thereby improving the accuracy of the user's measurement of the pumping flow rate and the total fluid flow rate of the catheter pump 306, and helping the user to study and evaluate the hemodynamic characteristics and operating stability of the catheter pump 306 in complex clinical scenarios.

[0061] Specifically, the aortic valve clamping device 200 further includes a pressure piece 250. When the inlet flange 210 and the outlet flange 220 are mated, the pressure piece 250 can be pressed against the simulated aortic valve 230 under the pressure of the outlet flange 220, thereby pressing the simulated aortic valve 230 tightly into the inlet flange 210 and securing the simulated aortic valve 230. The pressure piece 250 has an escape space on the side facing the simulated aortic valve 230 to avoid the opening and closing of the leaflets of the simulated aortic valve 230, preventing the leaflets of the simulated aortic valve 230 from interfering with the normal opening and closing of the leaflets, thereby affecting the simulation effect of the entire extracorporeal simulated circulation device.

[0062] In a preferred embodiment, when the inlet flange 210 and the outlet flange 220 compress the pressing piece 250 and the simulated aortic valve 230, the side of the pressing piece 250 facing the inlet flange 210 can abut against the end of the bypass tube 221 located within the aortic valve clamping device 200. This facilitates the distal end of the catheter pump 306 to pass directly into the pressing piece 250 after exiting the bypass tube 221, thus facilitating the installation of the catheter pump 306. A second sealing gasket 260 is further disposed between the pressing piece 250 and the bypass tube 221. The inner diameter of the second sealing gasket 260 is consistent with the maximum outer diameter of the catheter pump 306. In this way, when the inlet flange 210 and the outlet flange 220 press the pressing piece 250 and the simulated aortic valve 230, the pressing piece 250 will squeeze the second sealing gasket 260 and deform it until the inner wall surface of the second sealing gasket 260 is pressed against the outer wall surface of the catheter pump 306. This not only solves the problem of fixing the catheter pump 306 in the aortic valve clamping device 200, but also plays a sealing role, so that the fluid pumped by the catheter pump 306 can completely flow out from the bypass pipe 221, and the data measurement is more accurate.

[0063] In addition, by providing a second sealing gasket 260, this embodiment can also make the pressure piece 250 and the bypass tube 221, as well as the pressure piece 250 and the simulated arterial valve 230, elastically pressed together, not easily damaged, and having a longer service life. It can measure the stability of the flow rate and pressure during long-term operation of the catheter pump 306, which is more conducive to users testing and studying the hemodynamic characteristics and operational stability of the catheter pump 306 in complex clinical scenarios.

[0064] Specifically, the extracorporeal circulation simulation system further includes a first flow meter (not shown), which is installed on the simulation branch 314 and is used to detect the flow on the simulation branch 314, thereby obtaining the actual pumping flow of the catheter pump 306. Figure 1 The extracorporeal circulation simulation system further includes a second flow meter 313, which is installed on the simulation pipeline 305 after merging with the simulation branch 314, and is used for the user to obtain the total fluid flow.

[0065] Furthermore, the extracorporeal circulation simulation system also includes a first pressure sensor 307 and a second pressure sensor 308, wherein the first pressure sensor 307 is arranged in the simulation pipeline 305 and is located on the side of the inlet flange 210 away from the outlet flange 220, for measuring ventricular pressure; the second pressure sensor 308 is arranged in the simulation pipeline 305 and is located on the side of the outlet flange 220 away from the inlet flange 210, for measuring arterial pressure.

[0066] Specifically, when the extracorporeal simulated circulatory system is used to simulate the left ventricle with the assistance of a catheter pump 306, the ventricular simulation device 100 is used to simulate the left ventricle, the simulated aortic valve 230 is used to simulate the aortic valve, and the simulated tube 305 is used to simulate the aorta. In this case, the first pressure sensor 307 is used to measure the left ventricular pressure, and the second pressure sensor 308 is used to measure the aortic pressure. When the extracorporeal simulated circulatory system is used to simulate the right ventricle with the assistance of a catheter pump 306, the ventricular simulation device 100 is used to simulate the right ventricle, the simulated aortic valve 230 is used to simulate the pulmonary valve, and the simulated tube 305 is used to simulate the pulmonary artery. In this case, the first pressure sensor 307 is used to measure the right ventricular pressure, and the second pressure sensor 308 is used to measure the pulmonary artery pressure.

[0067] In an exemplary embodiment, the first valve 315 is located on the side of the inlet flange 210 away from the outlet flange 220, and the second valve 316 is located on the side of the outlet flange 220 away from the inlet flange 210. At this time, the end of the analog branch 314 connected to the analog pipeline 305 is preferably located between the second valve 316 and the second pressure sensor 308.

[0068] Among them, see Figure 1The optimal arrangement is that the second valve 316 is located on the side of the second pressure sensor 308 close to the aortic valve clamping device 200, and one end of the simulation branch 314 connected to the simulation pipeline 305 is located between the second valve 316 and the second pressure sensor 308.

[0069] In this embodiment, by disposing the second pressure sensor 308 at a position after the confluence of the analog branch 314 and the analog pipeline 305, it is more convenient for the user to obtain arterial pressure and evaluate the actual performance of the catheter pump 306. At the same time, the second valve 316 is disposed at a position before the confluence, which can realize the cutting off of the main circulation circuit (excluding the circulation circuit pumped by the catheter pump 306), and is more convenient for replacing the catheter pump 306. The structural arrangement is more reasonable and practical.

[0070] Specifically, see Figure 1 and Figure 4 The ventricular simulation device 100 includes a first simulation chamber 110, a second simulation chamber 120 located within the first simulation chamber 110, and a mounting frame 150 for securing the first and second simulation chambers 110 and 120. The first and second simulation chambers 110 and 120 are independent and isolated from each other, so that the ventricular simulation device 100 can form a highly airtight first medium cavity 130 between the first and second simulation chambers 110 and 120. The first simulation chamber 110 defines a medium flow port 140 connected to the first medium cavity 130. The medium can flow in and out of the first medium cavity 130 through the medium flow port 140, thereby changing the medium pressure within the first medium cavity 130. The second simulation chamber 120 is preferably made of elastic silicone and includes a second medium cavity 121 formed therein. The second medium cavity 121 communicates with a fluid outlet 160 and a fluid inlet 170 . By varying the medium pressure within the first medium cavity 130 , the stress state of the second simulation chamber 120 can be varied, allowing the medium within the second medium cavity 121 to enter the second medium cavity 121 through the fluid inlet 170 or exit the second medium cavity 121 through the fluid outlet 160 . For example, when the medium pressure in the first medium cavity 130 is greater than the medium pressure in the second medium cavity 121, and the pressure difference between the first medium cavity 130 and the second medium cavity 121 is greater than the minimum pressure required for the second simulation chamber 120 to deform, the second simulation chamber 120 is compressed and contracts, and the fluid in the second medium cavity 121 is discharged through the fluid outlet 160; when the medium pressure in the first medium cavity 130 is less than the medium pressure in the second medium cavity 121, and the pressure difference between the first medium cavity 130 and the second medium cavity 121 is greater than the minimum pressure required for the second simulation chamber 120 to deform, the second simulation chamber 120 expands, and the fluid enters the second medium cavity 121 through the fluid inlet 170.

[0071] This embodiment employs a first simulation chamber 110 disposed outside a second simulation chamber 120. Filling or pumping medium into a first medium cavity 130 formed between the first and second simulation chambers 110 enables the contraction and expansion of the second simulation chamber 120, thereby simulating the beating function of the human heart. The device features a simple structure and is easy to operate. Compared to conventional methods that use a motor to drive a piston to reciprocate to simulate the contraction and expansion of the heart, the ventricular simulator 100 provided in this embodiment has lower requirements for motor performance and control algorithms, making it easier to accurately simulate the pressure waveform of human blood.

[0072] Specifically, the medium in the first medium cavity 130 is air. At this time, the extracorporeal circulation simulation system includes an air pump and a controller for controlling the operation of the air pump. The medium flow port 140 is connected to the air pump through the trachea 302. The controller drives the air pump to periodically deliver and recover gas according to preset conditions (setting parameters such as pumping volume and pumping value according to the heart failure state to be simulated), thereby realizing the periodic contraction and relaxation of the second simulation chamber 120, thereby accurately simulating the beating function of the human heart in different states, driving the circulation of the fluid in the second simulation chamber 120, and building a pulsating environment simulating the physical state of heart failure patients, so as to test and study the hemodynamic characteristics and operating stability of the catheter pump 306 in complex clinical scenarios.

[0073] Among them, see Figure 1 The air pump and the controller can be integrated into an air pump control unit 301. A flow regulating valve 303 is also provided on the air pipe 302 to adjust the gas flow output by the air pump, thereby controlling the force of the medium in the first medium cavity 130 acting on the second simulation chamber 120, thereby achieving the ability to adjust the contraction and relaxation strength of the left ventricle.

[0074] Preferably, the number of medium flow ports 140 on the first simulation chamber 110 is preferably two, which are symmetrically arranged on opposite sides of the second simulation chamber 120, which is conducive to uniform force on the second simulation chamber 120, better and more stable pumping effect, and longer service life. At the same time, the two medium flow ports 140 are also more conducive to the rapid response of the second simulation chamber 120, more in line with the actual model of the human ventricle, and conducive to truly reflecting the various complex physiological states of heart failure patients.

[0075] Furthermore, the extracorporeal simulated circulatory system also includes a data acquisition system for receiving and displaying data from the first pressure sensor 307, the second pressure sensor 308, the first flow meter, and the second flow meter 313. Furthermore, the extracorporeal simulated circulatory system further includes an extracorporeal control device for driving the catheter pump 306 to move.

[0076] Further, see Figure 1The simulation circuit 305 is also equipped with an atrioventricular valve simulator 304, a damping valve 309, a compliance chamber 310, a venous cavity 311, and an atrial simulator 312. The compliance chamber 310 simulates the elasticity of the artery, the venous cavity 311 and the atrial simulator 312 simulate the vein and atrium, respectively. The atrioventricular valve simulator 304 simulates the function of the human atrioventricular valves (mitral valve and tricuspid valve). Specifically, when the extracorporeal simulated circulatory system is used to simulate the left ventricular catheter pump 306, the atrioventricular valve simulator 304 is used to simulate the mitral valve, and the atrial simulator 312 is used to simulate the left atrium. When the extracorporeal simulated circulatory system is used to simulate the right ventricular catheter pump 306, the atrioventricular valve simulator 304 is used to simulate the tricuspid valve, and the atrial simulator 312 is used to simulate the right atrium. A second flowmeter 313 is provided between the compliance chamber 310 and the venous cavity 311 to measure arterial flow. The damping valve 309 is used to regulate the arterial flow rate. The liquid flowing out of the venous cavity 311 flows back into the ventricular simulation device 100 through the damping valve 309, the atrial simulation device 312 and the atrioventricular valve simulation device 304.

[0077] Taking the example of an extracorporeal simulated circulatory system used to simulate the left ventricular catheter pump 306 assisting the patient, the extracorporeal simulated circulatory system provided in this embodiment should first be placed in the aortic valve clamping device 200. The air pump control unit 301 should be turned on to set the desired left ventricular pressure and heart rate. The data from the first pressure sensor 307, the second pressure sensor 308, and the second flowmeter 313 should be read. The flow control valve 303 should be adjusted to near the target value. The fluid level in the compliance chamber 310 and the damping valve 309 should then be adjusted to ensure that the left ventricular pressure, aortic pressure, and aortic flow meet the expected physiological characteristics of a heart failure patient. The extracorporeal control device should be used to start the catheter pump 306 and maintain it at a specific gear. After its speed stabilizes, the system's left ventricular pressure, aortic pressure, aortic flow, and the pumping flow of the catheter pump 306 should be read.

[0078] In addition to accurately simulating different heart failure states in the human body, this in vitro circulatory simulation device can also measure the extreme assistance effect of the catheter pump 306 and the stability of flow and pressure during long-term operation, facilitating the evaluation of the actual performance of the catheter pump 306. Furthermore, the system has a simple structure, low cost, and is easy to operate and maintain.

[0079] In the above embodiments, the description of each embodiment has its own focus. For parts that are not described or recorded in detail in a certain embodiment, reference can be made to the relevant description of other embodiments.

[0080] It should be noted that the above embodiments can be freely combined as needed. The above are only preferred implementations of the present application. It should be noted that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the present application, and these improvements and modifications should also be considered as the scope of protection of the present application.

Claims

1. An extracorporeal circulation simulation system, characterized in that: include: a ventricular simulation device having a fluid outlet and a fluid inlet; An arterial valve clamping device comprising an inlet flange, an outlet flange, and a simulated arterial valve sandwiched between the inlet flange and the outlet flange, wherein the inlet flange is connected to the fluid outlet, the outlet flange is connected to the fluid inlet, and the outlet flange is suitable for allowing a catheter pump to extend into the interior of the arterial valve clamping device and partially pass through the simulated arterial valve; The simulation pipeline is connected with the ventricle simulation device and the aortic valve clamping device, and the simulation pipeline is provided with a first valve and a second valve at both ends of the aortic valve clamping device.

2. The extracorporeal circulation simulation system according to claim 1, characterized in that: The outlet flange is provided with a bypass tube, one end of which is located inside the aortic valve clamping device, and the other end passes through the side wall of the outlet flange and extends to the outside of the outlet flange. The catheter pump extends into the interior of the aortic valve clamping device through the bypass tube.

3. The extracorporeal circulation simulation system according to claim 2, characterized in that: The aortic valve clamping device further includes a blocking member adapted to block an end of the bypass tube located outside the outlet flange.

4. The extracorporeal circulation simulation system according to claim 2, characterized in that: Also includes: The simulation branch connects the bypass pipe and the simulation pipeline.

5. The extracorporeal circulation simulation system according to claim 4, characterized in that: Also includes: The first flow meter is installed on the simulation branch and is used to detect the flow on the simulation branch.

6. The extracorporeal circulation simulation system according to claim 4, characterized in that: Also includes: a first pressure sensor and a second pressure sensor; The first pressure sensor is provided in the simulation pipeline and is located on a side of the inlet flange away from the outlet flange. The second pressure sensor is provided in the simulation pipeline and is located on a side of the outlet flange away from the inlet flange.

7. The extracorporeal circulation simulation system according to claim 6, characterized in that: The first valve is located on a side of the inlet flange away from the outlet flange, the second valve is located on a side of the outlet flange away from the inlet flange, and one end of the analog branch connected to the analog pipeline is located between the second valve and the second pressure sensor.

8. The extracorporeal circulation simulation system according to claim 7, characterized in that: The second valve is located on a side of the second pressure sensor close to the aortic valve clamping device.

9. The extracorporeal circulation simulation system according to any one of claims 1 to 8, characterized in that: The ventricular simulation device includes a first simulation chamber, a second simulation chamber located in the first simulation chamber, and a mounting frame for fixing the first simulation chamber and the second simulation chamber; The first simulation chamber and the second simulation chamber are isolated from each other, and a first medium cavity is formed between the first simulation chamber and the second simulation chamber. The first simulation chamber has a medium flow port connected to the first medium cavity. The second simulation chamber has a second medium cavity formed therein, and the second medium cavity is connected to the fluid outlet and the fluid inlet. The medium in the first medium cavity is suitable for applying pressure to the second simulation chamber, and the medium flow port is configured to allow the medium to flow so as to change the medium content in the first medium cavity and cause the second simulation chamber to expand or contract.

10. The extracorporeal circulation simulation system according to claim 9, characterized in that: Also includes: An air pump and a controller for controlling the operation of the air pump, wherein the air pump is connected to the medium flow port through an air pipe to fill or suck the medium into the first medium cavity.

Images